Vaginal pessary: a culprit for intraperitoneal bladder perforation.

Vaginal pessaries are widely considered to be a safe and effective non-surgical management option for women with pelvic organ prolapse. Complications may occur, and are more frequent with improper care and certain device designs and materials. It is imperative to provide information to patients about potential complications. We present the case of a woman in her 70s who presented to the Emergency Department with increasing groin and abdominal pain following a vaginal pessary insertion 2 days prior for grade 3 vaginal vault prolapse. On presentation, her abdomen was markedly distended with guarding. Laboratory investigations showed a significant acute kidney injury with a metabolic acidosis. An initial non-contrast CT showed fluid and inflammatory changes surrounding the bladder, and bladder perforation was suspected. A subsequent CT cystogram showed extravasation of contrast from the bladder into the peritoneal cavity, in keeping with an intraperitoneal bladder rupture. The patient underwent an emergency bladder repair in theatre.

A randomized clinical trial comparing internal and external pessaries in the treatment of pelvic organ prolapse in postmenopausal women: A pilot study.

INTRODUCTION AND HYPOTHESIS: Internal vaginal pessary is among the leading treatments for pelvic organ prolapse (POP); however, it has a high adverse event rate. An external pessary was recently developed as an alternative. The study's objective was to compare the efficacy of external and internal pessaries in treating POP in postmenopausal women. METHODS: This parallel randomized (1:1 ratio) open-blind study included 40 symptomatic women with stage 2 or 3 POP. They were randomized into two groups: group 1 (internal pessary) and group 2 (external pessary) (n = 20 in each); and evaluated at the start of and 3 months after the treatment. Statistical analysis was performed to compare the results within and between the groups before and after the 3-month treatment. RESULTS: The groups were homogeneous, except for the variables previous pregnancies (p = 0.030) and POP-Q score of apical prolapse (p = 0.023) whose values were higher in group 2. A significant improvement in quality of life was observed in both groups after 3 months of follow-up; however, internal pessaries were found to be more effective (p < 0.001). In group 1 there were differences between the initial and final POP-Q scores of anterior (0.004) and apical prolapse (p = 0.005). The complication rate associated with internal pessary use was high (p = 0.044). CONCLUSIONS: The present data suggested that external pessaries have a similar effect to internal ones for the treatment of POP and improvement of the quality of life of postmenopausal women.

Long-term continuations rate of ring pessary use for symptomatic pelvic organ prolapse.

PURPOSE: To evaluate long-term continuation rates, adverse events of ring pessary use at a minimum of 5 years follow-up, and factors associated with discontinuation in symptomatic pelvic organ prolapse (POP). METHODS: Women with symptomatic POP who were treated with vaginal ring pessary and had successful fittings were included. Adverse events and reasons for discontinuation of pessary use were recorded. Patients who were lost to follow-up were defined as discontinuation. RESULTS: During 12 year-period, 239 of 329 POP patients (72.6%) had successful fittings with ring pessary. The mean age was 67.8 ± 8.9 years (range 27-86) and 70% of patients had advanced stage. The cumulative probability of continued ring pessary use was 84.1%, 64.4%, 49.3%, and 33.5%, at 1, 3, 5, and 10 years, respectively. Most common reason for discontinuation was frequent expulsion (21.6%), followed by vaginal erosion (16.5%), no prolapse improvement (12.4%), and inability or inconvenience to do self-care (9.3%). However, 9 patients (9.3%) had improvement of prolapse and were able to discontinue pessary insertion. Age above 70 years, wide introitus, and incapability of self-care are independent factors associated with long-term discontinuation. Adverse events occurred in 23.4% of patients, 18.8% of them had vaginal erosion, 11.7% vaginal discharge/infection, and 18.4% de novo SUI. However, no statistical significance existed between those who continued and discontinued pessary use due to these adverse events. CONCLUSION: Ring pessary is an effective treatment in symptomatic POP, with acceptable long-term continuation rates and minor adverse events. Self-care of pessary is very important aiming to minimize adverse events. Advanced age, wide introitus and incapability of self-care were associated factors for long-term discontinuation.

The Impact of Vaginal Probiotics on Pessary Use: A Randomized Controlled Trial.

IMPORTANCE: Pessary-related adverse effects are common, and treatment options are limited. Probiotics may improve pessary-related adverse effects by altering the vaginal microenvironment. OBJECTIVE: This study aimed to evaluate the effect of a vaginal probiotic suppository on the vaginal microenvironment among pessary users. STUDY DESIGN: Women who used pessaries were randomized to vaginal probiotic suppository use versus without use. The intervention was a vaginal probiotic suppository and moisturizing vaginal gel. The vaginal microenvironment was assessed using Gram stain and Nugent's criteria at baseline and 3 months by a microbiologist blinded to group allocation. Symptoms and experience with use of the probiotic were assessed using questionnaires. The primary outcome was change in lactobacilli count on Nugent subscore at 3 months. RESULTS: A total of 147 postmenopausal women were randomized (86 to the intervention arm and 61 to the control arm), and 124 (87.9%) presented for a 3-month follow-up. There was no difference between the arms in age, race, body mass index, and Charlson Comorbidity Index. A majority of participants had the pessary managed by the health care professional (intervention arm vs control arm, 46 [76.7%] vs 55 [68.8%]; P = 0.30). Composition of the vaginal microenvironment did not differ with or without probiotic treatment at 3 months. Bother from vaginal symptoms, including discharge, itching, and discomfort, did not differ between arms. Adverse effects from the intervention were minor, resolved with discontinuation, and occurred at 39.1%. CONCLUSION: Vaginal probiotic suppository use did not affect the composition of the vaginal microenvironment, patient satisfaction, or vaginal symptoms after 3 months of use in pessary users.

Patient experience of pain during vaginal pessary removal and insertion: a service evaluation study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse is a common problem affecting women, but there is currently a lack of research focusing on patient experience of pessary changes. This study was aimed at capturing the patient perspective of pessary changes and formally assessing pain during pessary removal and insertion. METHODS: A service evaluation request was granted by South Tees Hospitals NHS Trust. Patients undergoing pessary change (ring, shelf, or Gellhorn) in gynaecology outpatient clinics over a 6-month period were asked to rate their pain scores on a ten-point numerical pain-rating scale. Other associated data were collected. RESULTS: Out of 213 women, 58.2% reported that pessary removal was more painful than insertion, 30.5% reported equal pain, and 10.8% reported that insertion was more painful than removal. Pain scores were significantly higher for removal (mean 4.37, median 4, IQR 4-7) than for insertion (mean 2.66, median 2, IQR 2-4, p <0.001). Ring pessaries were significantly less painful to both remove and insert than shelf and Gellhorn pessaries. Smaller pessaries were more painful to both remove and insert. There was no significant difference in pain scores reported by those with or without diagnosed vulval conditions. CONCLUSIONS: Pessary removal causes most women moderate pain, which should be communicated to patients beforehand. Ring pessaries are significantly less painful to change than other pessary types. Clinicians should consider pain as a factor in their decision-making surrounding pessary choice and when counselling patients. Future research should focus on ways to reduce pain during pessary removal.

Pessaries for pelvic organ prolapse: evaluation of vaginal discharge and pain during pessary cleaning in an outpatient setting.

INTRODUCTION AND HYPOTHESIS: Pessary treatment for pelvic organ prolapse (POP) is effective and safe, but long-term continuation is low. Pain and vaginal discharge may play a role. This study was aimed at evaluating vaginal discharge and pain during pessary cleaning in an outpatient setting and in continuous pessary use. METHODS: Women with POP who attended the outpatient clinic for pessary cleaning between January and October 2021 were included. Primary outcome was pain during removal and reinsertion of the pessary, measured by an 11-point numeric rating scale (NRS). Secondary outcome was vaginal discharge, measured by the NRS and Patient Global Impression of Change scale (PGI-C). Multiple linear regression analysis was used to identify associated variables for pain and discharge. RESULTS: A total of 150 women were included. Mean NRS during pessary removal was 4.3 (± 2.7), with 25% of women scoring a 7 or higher. Mean NRS during reinsertion was 1.8 (± 2.0). A smaller genital hiatus and presence of vaginal atrophy or vulvar skin disease were associated with pain during pessary removal. Mean NRS for vaginal discharge was 2.5 (± 2.3). Twenty-five percent of women reported that their vaginal discharge was "(very) much worse" than before they used a pessary. Presence of vaginal erosions was associated with vaginal discharge in this study population. CONCLUSIONS: Removing a pessary in an outpatient setting is a painful procedure for many women who use a pessary continuously. Moreover, 25% of these women experience an increase in vaginal discharge while using a pessary. Future research should focus on reducing these disadvantages.

Management of short cervix in twin-to-twin transfusion syndrome: a role for pessary placement following fetoscopic laser surgery?

BACKGROUND: Preterm labor and delivery is a major concern for patients with twin-to-twin transfusion syndrome undergoing fetoscopic laser surgery. A preoperative short cervix is a risk factor for preterm labor. Pessary placement is a short-acting intervention that may be useful to reduce this adverse event. OBJECTIVE: This study aimed to investigate the relationship between pessary placement and preterm delivery in monochorionic twin pregnancies with twin-to-twin transfusion syndrome and a short cervix before fetoscopic laser surgery. STUDY DESIGN: This was a retrospective study in 2 centers, including all pregnancies affected by twin-to-twin transfusion syndrome that underwent fetoscopic laser surgery with the Solomon technique between 2013 and 2022 (center A) and 2014 and 2022 (center B) with a preoperative cervical length below 25 mm. This study explored the correlation between cervical length and fetoscopic laser surgery-to-delivery interval following active or expectant management and compared perinatal outcomes between patients managed expectantly and patients managed with pessary placement, using multivariate analysis to control for potential confounders. Patients with a cervical length below 5 mm were not included in the comparative analysis. RESULTS: Of 685 patients, 134 met the inclusion criteria. Moreover, 21 patients were treated with a cervical cerclage and excluded from the analysis, leaving 113 patients for the final analysis. There was a significant negative correlation between cervical length at fetoscopic laser surgery and the risk of early delivery (adjusted odds ratio, 0.66; 95% confidence interval, 0.49-0.81; P<.001). The use of a pessary correlated with fewer patients delivering before 28 weeks of gestation (adjusted odds ratio, 0.28; 95% confidence interval, 0.09-0.75), fewer double neonatal demise (adjusted odds ratio, 0.2; 95% confidence interval, 0.05-0.75). Posthoc subgroup analysis suggested that these improvements were essentially noticeable for cervical lengths between 5 and 18 mm, where pessary placement was associated with an increased fetoscopic laser surgery-to-delivery interval (+24 days; 95% confidence interval, 0.86-42; P=.042) and later gestational age at delivery (+3.3 weeks; 95% confidence interval, 0.86-42; P=.035). CONCLUSION: Patients with a moderately shortened cervix, between 5 and 18 mm, may benefit from pessary placement after fetoscopic surgery for twin-to-twin transfusion syndrome, resulting in a reduction of adverse neonatal outcomes, double neonatal demise, and severe preterm delivery.

Outcomes in Women With Pelvic Organ Prolapse Presenting With Pessary-Related Complications.

IMPORTANCE: There is currently a paucity of data describing the outcomes of women with pelvic organ prolapse (POP) and/or urinary incontinence (UI) who present with pessary-related complications. OBJECTIVE: This study aimed to describe outcomes in women with POP and UI managed with a pessary who present with pessary-related complications. STUDY DESIGN: This was a retrospective cohort study of women with POP and/or UI who elected for management with a pessary from January 1, 2016, to December 31, 2020. Patients were included if they had used a pessary for at least 1 year and had a documented pessary-related complication. Complications were defined a priori, and patient charts were abstracted using International Classification of Diseases, Ninth and Tenth Revisions codes associated with pessary use. RESULTS: Of 2,088 of women receiving pessary care, 444 (21%) experienced a complication. Of 154 of women, 34.6% experienced 2 pessary-related complications during the study period, whereas 12.6% (56) experienced 3, 4.5% (20) experienced 4, and 1.8% (8) experienced 5. One hundred fifty-two patients (34.2%) underwent surgery during the study period to manage their POP and/or UI. Patients who were older were less likely to have surgery (adjusted odds ratio, 0.70 [95% confidence interval, 0.20-0.90]; P = 0.002), and patients who had an indication of pessary use for both POP and UI were more likely to undergo surgery during the study period (adjusted odds ratio, 2.12 [95% confidence interval, 1.29-3.48]; P = 0.003). CONCLUSIONS: Our results suggest that 1 in 5 patients has a documented complication associated with pessary use of greater than 1 year. Of these patients, one third will eventually undergo surgery for management of their POP and/or UI.

Long-term adherence to pessary use in women with pelvic organ prolapse: A retrospective cohort study.

PURPOSE OF THE RESEARCH: Vaginal pessary use is an established, non-surgical treatment option for pelvic organ prolapse. While satisfaction rates are initially high, they seem to decline over time. We aimed to determine the median duration of pessary use among our patients and to evaluate reasons for discontinuation. METHODS: All patients who were treated with a vaginal pessary for pelvic organ prolapse between 2007 and 2022 at our institution (a maximum observation period of 15 years) were included in this retrospective cohort study. Data were collected from the in-house electronic databases and the date of pelvic floor surgery was defined as the primary endpoint. In case of no documented surgery, the date of the last follow-up visit (for patients lost to follow-up or who discontinued pessary use without subsequent surgery) or the date of final data collection (for those with presumed continued pessary use) was used as the primary endpoint. Duration of pessary use is represented by Kaplan-Meier curves. Effects of possible confounders were investigated by Cox regression models. A Cox regression model was evaluated for patients with the three most common types of pessary: ring, cube and shell. A chi-square test was performed to compare therapy adherence according to pessary type. PRINCIPAL RESULTS: Data of 779 patients could be included in the statistical analysis. The estimated median duration of pessary use was 173 weeks (95 % CI 104-473) - approximately 3.3 years. Overall, 30 % of patients opted for surgical therapy and the majority of them did so within 4 months of initiation of pessary use (median time: 19 weeks, 95 % CI 16-26). In 5 % of cases a discontinuation of pessary use without subsequent surgery was documented and 18 % were lost to follow-up before a planned visit, thus leaving 47 % of our patients with presumed continued pessary use. Possible confounding factors for discontinuation of pessary use were tested but were found to be non-significant (body mass index, Pelvic Organ Prolapse - Quantification score, pelvic floor training, age, parity, menopausal status, nicotine consumption, incontinence or size of pessary). Reasons for discontinuation of pessary use were documented in 51 % of patients: unspecified patient wish (23 %), pessary use tiredness (10 %), general dissatisfaction with pessary therapy (7 %), unspecified reasons (5 %), pessary self-change not possible (1 %), erosion, bleeding, pain (2 %); none of the pessary types fitted (2 %). CONCLUSIONS: According to our data, almost half of our patients with pelvic organ prolapse and pessary therapy continued pessary use until a maximum follow-up time of 15 years, whereas about one-third of patients finally opted for surgical repair (a majority of these within 4 months after pessary therapy initiation). The remaining patients were either lost to follow-up or discontinued pessary use without subsequent surgery. The stated reasons for discontinuation of pessary use were mostly non-specific, but only 1 % reported that pessary self-change was not possible. Erosion bleeding or pain was documented in only 2 % of cases as reason for discontinuation. This information helps clinicians to inform their patients with pelvic organ prolapse about expected pessary therapy success and strengthens individual counselling. Furthermore, our data indicates vaginal pessary use for pelvic organ prolapse is feasible and safe for all women and that therapy adherence can extend beyond 5 years.

Are older patients with prolapse likely to continue pessary use? A retrospective observational study.

INTRODUCTION AND HYPOTHESIS: To review the outcomes and complications of vaginal prolapse management with pessaries in women aged 75 years or older, to ascertain whether pessaries are providing satisfactory long-term outcomes for older women. METHODS: A retrospective observational study was performed on women aged 75 years or older presenting to a tertiary Urogynaecology service with vaginal prolapse who opted for management with a vaginal pessary. Demographic and clinical data were collected by reviewing clinical files. The primary outcome was the proportion of women who opted for pessary management who later required prolapse surgery. Secondary outcomes included pessary complications and risk factors for failure. Kaplan-Meier survival estimates were performed to analyse pessary failure. RESULTS: Of the 218 women who presented with prolapse, 78% opted for pessary management, and pessary fitting was successful in 84%. Sixty-nine percent of women who opted for initial pessary management underwent surgery later, with a mean time from pessary insertion to surgery of 21.6 months. Vaginal erosions were reported in 42% of pessary users. Risk factors for pessary failure were younger age and previous history of hysterectomy or prolapse surgery. CONCLUSIONS: Although vaginal pessary use was the preferred first-line management choice for vaginal prolapse in most older women, surgery for prolapse was ultimately required in two-thirds of those conservatively managed. As three-quarters of older women presenting with prolapse had surgery as either a primary or secondary procedure; patients need to be advised of the high chance of requiring surgery at a later stage if they opt for pessary management.

Evaluating compliance and applicability of postpartum pessary use for preventing and treating pelvic floor dysfunction: a prospective multicenter study.

PURPOSE: Pelvic floor disorders are common and associated with pregnancy and childbirth. For restitution of pelvic floor connective tissue and thereby therapy of postpartum pelvic organ prolapse and stress urinary incontinence, the Restifem® pessary is approved. It supports the anterior vaginal wall behind the symphysis, the lateral sulci and the sacro-uterine ligaments and stabilises the connective tissue. We evaluated the compliance and applicability of Restifem® use in women postpartum in a preventive and therapeutic approach. METHODS: Restifem® pessary was handed out to 857 women. Six weeks after birth, they started the pessary use. After 8 weeks, 3 and 6 months postpartum, women received a questionnaire via online survey for evaluation of pessary applicability and efficacy. RESULTS: After 8 weeks, 209 women answered the questionnaire. 119 women used the pessary. Common problems were discomfort, pain and the pessary use was to circuitous. Vaginal infections were rare. After 3 months, 85 women and after 6 months, 38 women still used the pessary. 3 months postpartum, 94% of women with POP, 72% of women with UI and 66% of women with OAB stated to have an improvement of their symptoms using the pessary. 88% women without any disorder felt an improvement of stability. CONCLUSIONS: Use of the Restifem® pessary in the postpartum period is feasible and accompanied with less complications. It reduces POP and UI and leads to an increased sense of stability. So, Restifem® pessary can be offered to women postpartum to improve pelvic floor dysfunction.

A novel aspiration technique to assess cervical remodelling in patients with or without cervical shortening: Sequence of first changes, definition of cut-off values and impact of cervical pessary, stratified for cervical length.

BACKGROUND: The therapeutic significance of the cervical pessary has been confirmed by several studies. However, the underlying mechanism by which pessaries reduce the risk of a preterm birth remains elusive. The aim of this study is to investigate the hypothesis whether the application of a cervical pessary may stabilize the ectocervical stiffness in order to achieve a cervical arrest. METHODS: This is a prospective, controlled, non-interventional, post-market, monocentric, longitudinal, cohort study in a tertiary maternity hospital to determine ectocervical stiffness and its changes measured before and after placement of a pessary in singleton pregnancies with cervical shortening in the mid trimester. In order to assess reference values for cervical stiffness, we measured also singleton pregnancies with normal cervical length in the same gestational week spectrum. The cervical stiffness measured with the Pregnolia System as the Cervical Stiffness Index (CSI, in mbar) shall be the primary endpoint, whilst patient delivery data (gestational age, mode of delivery and complications) will be the secondary endpoint. In this pilot study, up to 142 subjects will be enrolled to have a total of 120 subjects (estimated dropout rate of 15%) to complete the study; pessary cohort: 60 (up to 71 recruited), control group: 60 (up to 71 recruited). DISCUSSION: Our hypothesis is that patients with cervical shortening will present with lower CSI values and that pessary placement will be able to stabilize the CSI values through further prevention of cervical remodelling. The measurement of controls with normal cervical length shall serve as a reference.

Nonoperative Management of Pelvic Organ Prolapse.

Pelvic organ prolapse (POP) is defined as the descent of one or more of the anterior, posterior, or apical vagina. It is a common condition, with up to 50% of women having prolapse on examination in their lifetimes. This article provides an overview of the evaluation and discussion of nonoperative management of POP for the obstetrician-gynecologist (ob-gyn), with consideration of recommendations from the American College of Obstetricians and Gynecologists, the American Urogynecologic Society, and the International Urogynecological Association. The initial evaluation of POP requires a history documenting whether the patient is experiencing symptoms and what they are, and discovery of which symptoms they believe are attributable to prolapse. Examination determines the vaginal compartment(s) and to what degree prolapse exists. In general, only patients who have symptomatic prolapse or medical indication should be offered treatment. Although surgical options exist, all patients who are symptomatic and desire treatment should be offered nonsurgical treatment first, including pelvic floor physical therapy or a pessary trial. Appropriateness, expectations, complications, and counseling points are reviewed. Educational opportunities between the patient and the ob-gyn include disentangling common beliefs that the bladder is dropping or that concomitant urinary or bowel symptoms are necessarily caused by prolapse. Improving patient education can lead to a better understanding of their condition and better alignment of treatment goals and expectations.

Patient-reported goal achievements after pelvic floor muscle training versus pessary in women with pelvic organ prolapse. A randomised controlled trial.

The aim was to assess the achievement by self-determined goals in pelvic organ prolapse (POP) participants receiving pelvic floor muscle training (PFMT) compared to vaginal pessary. Forty participants with POP stage II to III were randomly allocated to pessary or PFMT. Participants were asked to list up 3 goals they expected from treatment. Thai version of Prolapse Quality of Life Questionnaire (P-QOL) and Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) were completed at 0 and 6-week period. At 6-week post-treatment, they were asked if their goals had been achieved. The totally achieved goals in the vaginal pessary group were 70% (14/20) significantly higher than PFMT group at 30% (6/20) (p = 0.01). The mean ± SD of the post-treatment P-QOL score in the vaginal pessary group was significantly lower than the PFMT group (13.90 ± 10.83 vs 22.04 ± 5.93, p = 0.01), but not different in all PISQ-IR subscales. Pessary treatment for POP yielded better total goal achievements and better quality of life than PFMT for POP treatment at a 6-week follow-up.Impact statementWhat is already known on this subject? Pelvic organ prolapse (POP) can severely affect the quality of life, causing physical, social, psychological, occupational, and/or sexual dysfunction. Individual patient goal setting and goal achievement scaling (GAS) offers a new method of patient-reported outcome measurement (PRO) in therapeutic success such as pessary or surgery in patient with POP. But there is no randomised controlled trial comparing pessary vs pelvic floor muscle training (PFMT) using GAS as the outcome measurement.What do the results of this study add? The results showed that women with POP stage II to III who received vaginal pessary had higher totally goal achievements and better quality of life than the women received the PFMT at 6-week follow up.What are the implications of these findings for clinical practice and/or further research? The information about the better goal achievements by using pessary can be used as the tools for counselling for patients with POP for selecting the choices for the treatment in the clinical setting.

POP stage II to III patients treatedwith vaginal pessary had higher totally goal achievements and better quality of life than treated by PFMT.

Transition to surgery after pessary among female Medicare beneficiaries with pelvic organ prolapse.

BACKGROUND: The American College of Obstetricians and Gynecologists recommends offering a vaginal pessary to women seeking treatment of pelvic organ prolapse. However, single-institution series have suggested that a sizable proportion of women fitted with a pessary will transition to surgery within the first year. OBJECTIVE: This study aimed to estimate the proportion of female US Medicare beneficiaries with pelvic organ prolapse who undergo surgery after pessary fitting, to describe the median time to surgery from pessary fitting, and to identify factors associated with the transition from pessary to surgery. STUDY DESIGN: The Medicare 5% Limited Data Set was queried from 2011 to 2016 for women aged ≥65 years with a diagnosis of prolapse who underwent pessary fitting. Cases with at least 3 years of follow-up in the Medicare Data Set were followed longitudinally for the primary outcome of surgery for prolapse. The cumulative incidence of prolapse surgery following index pessary fitting was calculated. Characteristics of women who underwent surgery and those who did not were compared using time-varying Cox regression analysis. RESULTS: Among 2032 women fitted with a pessary, 608 underwent surgery within 7 years. The median time to surgery was 496 days (interquartile range, 187-1089 days). The cumulative incidence of prolapse surgery was 12.2% at 1 year and 30.9% at 7 years. After adjusting for covariates, factors significantly associated with the transition to surgery included previous prolapse surgery (adjusted hazard ratio, 1.50; 1.09-2.07) and a diagnosis of urinary incontinence at the time of pessary fitting (adjusted hazard ratio, 1.20; 0.62-0.99). Factors associated with a lower hazard of surgery included age (adjusted hazard ratio, 0.96 per year; 95% confidence interval, 0.95-0.97), dual Medicare/Medicaid eligibility (adjusted hazard ratio, 0.75; 95% confidence interval, 0.56-1.00), and pessary fitting by a nongynecologist (adjusted hazard ratio, 0.78; 95% confidence interval, 0.62-0.99). CONCLUSION: In this population of Medicare beneficiaries, within 7 years of pessary fitting, almost one-third of women aged >65 years underwent surgery for prolapse. These results add to our current understanding of the demographics of pessary use in an older population and may aid in counseling older patients presenting for treatment of symptomatic pelvic organ prolapse.

Adverse events associated with pessary use over one year among women attending a pessary care clinic.

INTRODUCTION AND HYPOTHESIS: The primary objective was to determine the adverse event rate associated with pessary use. Secondary objectives were to determine discontinuation, patient satisfaction, and factors associated with adverse events. METHODS: A retrospective observational study included patients attending a nurse-led pessary clinic with ≥ 1 year follow-up. Patients were fitted with a pessary by a urogynecologist and pessary care by a nurse was performed every 3-4 months. Demographic characteristics, pessary fitting, adverse events, their management and discontinuation were recorded. Pearson Chi-square and Fisher exact tests assessed the association between predetermined risk factors and pessary complications or discontinuation. Relative risk and 95% confidence intervals were computed. RESULTS: 215 women were followed for a mean (standard deviation) of 4.4 (1.9) years. Mean age was 73.8 (8.7) years. Adverse event rate was 83.7%; most commonly vaginal discharge, vaginal bleeding and erosions. Women with cardiovascular risk factors were less likely to develop pessary-related adverse events (79.7% vs. 91.9%, p = 0.03). Gellhorn and donut pessaries were more commonly associated with pessary erosions than ring with support pessaries or incontinence rings (RR 2.37 [1.67; 3.38]). Thirty-five (16.3%) women discontinued pessary use at a mean of 3.3 (1.7) years after initial fitting. Having a pessary erosion was not associated with discontinuation (p = 0.698), but recurrent erosions were (p = 0.012). CONCLUSION: Adverse events were common among women continuing to use pessaries past 1 year, but adherence and satisfaction rates remained high after 4.4 years. Pessary type and absence of cardiovascular factors were associated with pessary-related adverse events.

Self-management of vaginal cube pessaries may be a game changer for pelvic organ prolapse treatment: a long-term follow-up study.

INTRODUCTION AND HYPOTHESIS: Loss of anatomical support for the pelvic organs results in pelvic organ prolapse (POP). We hypothesized that daily self-management of a cube pessary might be a safe, feasible long-term treatment in women with symptomatic POP. METHODS: A cohort of 214 symptomatic POP patients (stage 2+) were enrolled prospectively (January to December 2015). Each patient was size-fitted with a space-filling cube pessary and completed a questionnaire online or by phone ≥5 years after her initial fitting. Change in quality of life (QoL) was measured with the Patient Global Impression of Improvement (PGI-I). RESULTS: Of 185 women included in our analyses, 174 (94%) were continuing to use their pessary 4 weeks post-insertion. Among those, 143 (82.2%) used the pessary successfully for ≥5 years. A large majority of these patients (88.8% [127 out of 143]) described their condition as much or very much improved compared with their pretreatment status (PGI-I). Adverse secondary effects (ASEs) were infrequent [15.4% (22 out of 143)]; when they did occur, they were mild, including smelly vaginal discharge (15 out of 22) and slight vaginal bleeding caused by the fitting procedure (6 out of 22). CONCLUSIONS: Daily self-management of cube pessaries was found to be a safe and effective treatment for improving POP-related symptoms and QoL in the long term.